Director Legal, Manufacturing Division

Merck; Pennsylvania; On-site; USD 150,000 - 230,000; Full time

Job summary

Scorpion Therapeutics operates in a regulated biopharma environment, and this role provides legal support to manufacturing compliance (cGMP) and regulatory interactions. The candidate will help ensure quality, supply chain, and manufacturing agreements align with regulatory standards.

Key responsibilities include advising on submissions, inspections, and regulatory documents, and coordinating with agencies like the FDA and EMA while managing related legal risks and strategy.

Qualifications

• JD from an accredited US law school.
• Admitted to NJ or equivalent bar.
• 5+ years regulatory law experience in pharma or with cGMP expertise.
• Strong communication, analytical and multitasking skills.

Responsibilities

• Advise on regulatory submissions, inspections and cGMP compliance.
• Manage manufacturing-related legal risks and strategy.
• Review regulatory documents and interactions with FDA/EMA.

Skills

Regulatory compliance

cGMP knowledge

Regulatory submissions

FDA interactions

Legal risk management

Education

Juris Doctor (JD)

Job description

Role:

Provide legal support to manufacturing compliance (cGMP) and regulatory interactions within a biopharma context, focusing on quality, supply chain, and manufacturing agreements.

Responsibilities:

advise on regulatory submissions, inspections, and compliance with cGMP; manage manufacturing-related legal risks and strategy; review regulatory documents and interactions with agencies like FDA/EMA.

Requirements:

JD from an accredited US law school, admission to NJ or equivalent bar; 5+ years regulatory law experience, preferably in pharma or with cGMP expertise; strong communication, analytical, and multitasking skills.

HighValue:

experience with pharmaceutical manufacturing, regulatory agencies (FDA, EMA), and cGMP regulations; exposure to manufacturing compliance, regulatory inspections, and pharmaceutical law.

WorkSetup:

hybrid in NJ or PA (Rahway, North Wales, Upper Gwynedd); 10% travel.